STRABEN 8.75 mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Straben, 8.75 mg, Hard Lozenges
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Straben and what is it used for
4. Important information before taking Straben
   1. When not to take Straben
   2. Warnings and precautions
   3. Children
   4. Straben with other medicines
   5. Straben with alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Straben contains sorbitol
   9. Straben contains lactose
5. How to take Straben
   1. Do not take more than 5 hard lozenges per day.
   2. Use in children
   3. Elderly patients
   4. Taking a higher dose of Straben than recommended
   5. Missing a dose of Straben
6. Possible side effects
   1. Reporting side effects
7. How to store Straben
8. Contents of the pack and other information
   1. What Straben contains
   2. What Straben looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 19.01.2024

Package Leaflet: Information for the User

Straben, 8.75 mg, Hard Lozenges

Flurbiprofen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• -Keep this leaflet, you may need to read it again.
• -If you need advice or additional information, consult a pharmacist.
• -If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• -If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

• 1. What is Straben and what is it used for
• 2. Important information before taking Straben
• 3. How to take Straben
• 4. Possible side effects
• 5. How to store Straben
• 6. Contents of the pack and other information

1. What is Straben and what is it used for

Straben contains flurbiprofen. Flurbiprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature. Straben is used for short-term relief of sore throat symptoms in adults and children over 12 years old.

2. Important information before taking Straben

When not to take Straben

• -If you are allergic to flurbiprofen, acetylsalicylic acid, and other nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• -If you have (or have had two or more episodes of) stomach ulcers, intestinal ulcers, or gastrointestinal bleeding.
• -If you have ever had allergic symptoms such as difficulty breathing (asthma), unexpected wheezing, shortness of breath, runny nose, facial swelling (angioedema), or itchy skin rash (hives) after taking acetylsalicylic acid or another NSAID.
• -If you have had gastrointestinal bleeding or perforation, severe ulcerative colitis (inflammatory bowel disease), or bleeding disorders while taking NSAIDs.
• -If you are taking high doses of acetylsalicylic acid (more than 75 mg per day) or another NSAID (e.g., celecoxib, ibuprofen, sodium diclofenac, etc.).
• -If you have severe heart, kidney, or liver failure.
• -In the last 3 months of pregnancy.

Warnings and precautions

Before taking Straben, discuss with your doctor or pharmacist if:

• •You currently have or have had asthma or allergies;
• •You are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid;
• •You have an infection - see "Infections" below;
• •You have heart, kidney, or liver problems;
• •You have had circulatory failure after a stroke;
• •You have had gastrointestinal diseases (such as ulcerative colitis, Crohn's disease);
• •You have a chronic autoimmune disease, such as systemic lupus erythematosus and mixed connective tissue disease;
• •You have persistent headaches;
• •You are at increased risk of conditions such as high blood pressure (hypertension), diabetes, or high cholesterol levels in the blood (hypercholesterolemia) or are a smoker;
• •You are elderly, as you are more likely to experience side effects listed in this leaflet;
• •You are pregnant or breastfeeding.

While taking Straben:

• -At the first signs of any hypersensitivity reaction (rash, skin peeling, blisters) or other signs of an allergic reaction, stop taking Straben and consult a doctor.
• -Report any unusual abdominal symptoms (especially bleeding) to your doctor.
• -If there is no improvement or new symptoms appear, consult a doctor.
• -Medicines like flurbiprofen may slightly increase the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term use.

Do not exceed the recommended dose and duration of treatment (see section 3).
Infections
Nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the symptoms of infection, such as fever and pain. This may delay appropriate treatment of infections, which can lead to increased risk of complications. If you are taking this medicine during an ongoing infection and your symptoms persist or worsen, consult a doctor or pharmacist immediately.

Children

Do not give Straben to children under 12 years old.

Straben with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, if you are taking:

• high doses of acetylsalicylic acid (more than 75 mg per day);
• medicines for high blood pressure or used to treat heart failure (antihypertensives, cardiac glycosides);
• diuretics, including potassium-sparing diuretics (e.g., spironolactone);
• medicines used to reduce blood clotting (anticoagulants, antiplatelet agents);
• medicines used to treat gout (e.g., probenecid, sulfinpyrazone);
• another NSAID (such as celecoxib, ibuprofen, sodium diclofenac) or a corticosteroid medicine (e.g., prednisolone);
• mifepristone (a medicine used to terminate pregnancy);
• quinolone antibiotics (such as ciprofloxacin);
• cyclosporine or tacrolimus (medicines that suppress the immune system);
• phenytoin (a medicine used to treat epilepsy);
• methotrexate (a medicine used to treat autoimmune diseases or cancer);
• lithium or selective serotonin reuptake inhibitors (SSRIs) used to treat depression;
• oral antidiabetic medicines (medicines used to treat diabetes);
• zidovudine (a medicine used to treat HIV infections).

Straben with alcohol

Avoid drinking alcohol while being treated with Straben, as it increases the risk of stomach or intestinal bleeding.

Pregnancy, breastfeeding, and fertility

Oral forms (e.g., tablets) of flurbiprofen may cause side effects in the unborn child. It is not known if the same risk applies to Straben.
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Straben if you are in the last trimester of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney or heart problems in the unborn child. It may affect your and your child's tendency to bleed and cause late or longer-than-expected delivery. Do not take Straben during the first 6 months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is necessary during this period, use the smallest dose for the shortest possible time.
Taken for more than a few days, starting from the 20th week of pregnancy, Straben may cause kidney problems in the unborn child, which can lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If longer treatment is necessary, your doctor may recommend additional monitoring.
Flurbiprofen may appear in breast milk in very small amounts, so avoid taking Straben while breastfeeding.
Straben belongs to a group of medicines that may adversely affect female fertility. The effect is reversible after stopping the medicine. It is unlikely that occasional use of hard lozenges will affect fertility; however, inform your doctor before taking this medicine if you have difficulty getting pregnant. If Straben is used by a woman trying to conceive, use the smallest possible dose for the shortest possible treatment period.

Driving and using machines

Straben has no influence on the ability to drive and use machines.

Straben contains sorbitol

This medicine contains 577.34 mg of sorbitol in each hard lozenge. Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or if you have hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, consult your doctor before taking this medicine.

Straben contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Straben

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose for adults and children over 12 years old is one hard lozenge every 3 to 6 hours, as needed.

Do not take more than 5 hard lozenges per day.

Method of administration

• Take orally one hard lozenge and suck slowly.
• While sucking, always move the hard lozenge around the mouth.

Use in children

Do not give to children under 12 years old.

Elderly patients

Some elderly patients may be more susceptible to side effects.
These hard lozenges are intended for short-term use only. Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor or pharmacist immediately if your symptoms (such as fever and pain) persist or worsen (see section 2). In case of mouth irritation, discontinue treatment with Straben.
Do not take Straben for more than 3 days unless a doctor has told you to do so. If pain or new symptoms persist or worsen, consult a doctor or pharmacist.

Taking a higher dose of Straben than recommended

You may feel drowsy or nauseous. In case of overdose, even if you feel well, consult a doctor immediately.

Missing a dose of Straben

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Straben can cause side effects, although not everybody gets them.
By taking the smallest effective dose for the shortest duration necessary to relieve symptoms, you can minimize the risk of side effects.
Stop taking this medicine and tell your doctor immediatelyif you experience:

• allergic reaction symptoms such as asthma, wheezing, or shortness of breath for unknown reasons, itchy skin, runny nose, skin rashes, etc.
• facial swelling, tongue, or throat swelling causing difficulty breathing and low blood pressure leading to shock (these symptoms may occur even with the first dose of the medicine)
• severe skin reactions such as peeling, blistering, or skin shedding.

Tell your doctor or pharmacist if you notice any of the following side effects or any other side effects not listed in this leaflet:
Commonside effects (may affect up to 1 in 10 people)

• dizziness, headache
• throat irritation, sore throat
• mouth ulcers or mouth pain, discomfort, or unusual sensation in the mouth (such as warmth, tingling, or prickling)
• nausea, diarrhea
• skin tingling, skin burning sensation

Uncommonside effects (may affect up to 1 in 100 people)

• drowsiness
• blisters in the mouth or throat, numbness in the throat
• abdominal bloating, abdominal pain, gas, constipation, indigestion, vomiting
• dry mouth, altered taste, burning sensation in the mouth
• skin rash, itchy skin
• fever, pain
• feeling drowsy or having difficulty sleeping
• worsening of asthma, wheezing, shortness of breath
• worsening of throat sensation

Rareside effects (may affect up to 1 in 1,000 people)

• allergic reaction and anaphylaxis
• kidney failure
• liver failure

Very rareside effects (may affect up to 1 in 10,000 people)

• blood disorders

Frequency not known(frequency cannot be estimated from the available data):

• anemia (reduced red blood cell count, which can cause pale skin and weakness or shortness of breath), thrombocytopenia (low platelet count, which can cause bruising and bleeding), neutropenia (low white blood cell count),

agranulocytosis (significant decrease in white blood cell count, which increases the risk of infection)
high blood pressure (hypertension), heart failure, or heart attack (heart problems that can cause shortness of breath or swelling of the ankles)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Straben

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated.
No special precautions for storage temperature are necessary.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Straben contains

• The active substance is flurbiprofen. One hard lozenge contains 8.75 mg of flurbiprofen.
• The other ingredients are: lactose monohydrate, magnesium stearate (E572), orange flavor (containing: natural flavoring substances, flavoring preparations, corn maltodextrin, modified cornstarch, silicon dioxide), colloidal anhydrous silica, sorbitol (E420), cornstarch, talc (E553b).

What Straben looks like and contents of the pack

Straben is a flat, white hard lozenge.
One carton contains 20 hard lozenges, packaged in 2 blisters of OPA/Aluminum/PVC/Aluminum foil, each containing 10 hard lozenges, with a patient information leaflet.

Marketing authorization holder and manufacturer

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
14 km National Road 1
GR-145 64 Kifisia
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Malta: Straben 8.75 mg lozenges
Poland: Straben 8.75 mg hard lozenges

Date of last revision of the leaflet: 19.01.2024